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NovoLog Mix 70/30 insulin aspart 100 [iU]/mL Injection, Suspension — NDC 0169-3685-12 (Billing 00169-3685-12)

by Novo Nordisk Pharmaceutical Industries, LP · 1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS

This is a package of NovoLog Mix 70/30 insulin aspart 100 [iU]/mL Injection, Suspension from Novo Nordisk Pharmaceutical Industries, LP, marketed since Nov 2001 and currently FDA-listed; retail pharmacies pay about $6.93 per mL (NADAC). It is this product's only package size.

NDC 00169-3685-12
🏷️ FDA NDC (as labeled) 0169-3685-12 billing pads the labeler segment with a zero
Rx only Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 0169-3685-12 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
0169 labeler · 3685 product · 12 package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 0169368512 4
Medicaid fills, this package
1,130 prescriptions in the last four reported quarters
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0169-3685-12
Product NDC 0169-3685
11-digit billing NDC 00169368512
NCPDP billing unit ML — per mL (volume)
Application # BLA021172
SPL Set ID f999a4d9-129e-4cb2-88cb-2a855468882f
Established class (EPC) Insulin Analog
Chemical class Insulin
DEA schedule Non-controlled
Marketing category BLA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2001-11-01
Route SUBCUTANEOUS
Dosage form INJECTION, SUSPENSION
Substance INSULIN ASPART
Biologic (Purple Book) 351(a)

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 051718
GCN 19057
HICL code 023400
Ingredient (HICL) Insulin Aspart Prot/Insuln Asp
HIC1 code C
Therapeutic class — broad (HIC1) Electrolyte Balance/Metabolism/Nutrition
HIC2 code C4
Therapeutic class — intermediate (HIC2) Antihyperglycemics
HIC3 code C4G
Therapeutic class — specific (HIC3) Insulins
AHFS code 68:20.08.00
AHFS class Insulins
FDB label name NOVOLOG MIX 70-30 VIAL
FDB brand name Novolog Mix 70-30
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 051718
  • GCN: 19057
  • HICL (First Databank): 023400
  • AHFS class code: 68:20.08.00
Why two NDCs? The FDA registers this code as 0169-3685-12 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00169-3685-12. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

Clinical

Label name NOVOLOG MIX 70-30 VIAL Ingredient Insulin Aspart Prot/Insuln Asp
📖 What it is MedlinePlus · NLM

Insulin aspart injection is used to treat type 1 diabetes (condition in which the body does not produce insulin and therefore cannot control the amount of sugar in the blood) and type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Insulin aspart is a short-acting, man-made version of human insulin. Insulin aspart works by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from produc...

Read the full MedlinePlus article ↗
1
Nutrient depletion considerations

Insulin Aspart may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Insulin Aspart nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $6.929 $69.29 / 10 ml
Medicaid paysCMS SDUD · 12 mo $7.21 $72.11 / 10 ml
Medicare drug plans payPart D · Q2 2026 $6.91 $69.11 / 10 ml
Medicare Part B allowsASP · J1815 No ASP payment limit on file for J1815 this quarter.
NADAC price history (per mL) — tap or hover for the price & month
Sep 2021 Dec 2025 Apr 2026 Sep 2026 $29.009 $6.928
▼ Down 76% over the last 14 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Billing & reimbursement

FDA NDC (as labeled)0169-3685-12
11-digit billing NDC00169-3685-12
Format4-4-2 as registered → padded to 5-4-2 for billing (zero added to the labeler segment)
HCPCS J-codeJ1815
DescriptorINJECTION, INSULIN, PER 5 UNITS
Billing units / pkg20 units
How the units are derivedThis package is 10 ML; the HCPCS unit is 5 U, so one package = 20 billing units.
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00169-3685-12 You're viewing this Main listing 1 VIAL, GLASS in 1 CARTON / 10 mL in 1 VIAL, GLASS 2001-11-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
NovoLog Mix 70/30 100 [iU]/mLthis 00169-3685-12 Novo 1 vial $6.929 — Availability likely —
Insulin Aspart Protamine and Insulin Aspart Mix 70/30 100 [iU]/mL 73070-0200-11 Novo 1 vial $6.955 — Availability likely +0%
Fiasp 100 [iU]/mL 00169-3206-15 Novo 5 cartridges $8.569 — Availability likely +24%
Insulin Aspart Protamine and Insulin Aspart Mix 70/30 100 [iU]/mL 73070-0203-15 Novo 5 syringes $8.935 — Availability likely +29%
NovoLog Mix 70/30 100 [iU]/mL 00169-3696-19 Novo 5 syringes $8.937 — Availability likely +29%
NovoLog Mix 70/30 100 [iU]/mL 00169-2200-11 Novo 1 vial — — FDA listed —
NovoLog Mix 70/30 100 [iU]/mL 00169-2201-25 Novo 5 syringes — — FDA listed —
NovoLog Mix 70/30 100 [iU]/mL 50090-2272-00 A-S 5 syringes — — FDA listed —
.Insulin Aspart Protamine and Insulin Aspart 100 [iU]/mL 50090-4959-00 A-S 5 syringes — — FDA listed —
Insulin Aspart Protamine and Insulin Aspart Mix 70/30 100 [iU]/mL 70518-3236-00 REMEDYREPACK 5 syringes — — FDA listed —
NovoLog Mix 70/30 100 [iU]/mL 70518-2119-00 REMEDYREPACK 5 syringes — — FDA listed —
Novolog Mix 70/30 100 [iU]/mL 50090-4085-00 A-S 5 syringes — — Discontinued —
About this product: this is a biologic. Biologics don't have small-molecule generics — competition comes from FDA-licensed biosimilars (shown above), not generics.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & biosimilar status

🏛️
2000
First FDA approval
Jun 2000
📍
2026
Currently FDA-listed
26 years listed
🔓
2026
Biosimilars listed
2 FDA-licensed
🧬FDA-licensed biosimilars listed

1 biosimilar and 1 interchangeable are FDA-licensed for this reference biologic — see the list below. (Biologics have no small-molecule generics.)

FDA Purple Book — biosimilars & interchangeables ⓘ
Reference product
Fiaspinsulin aspart Novologinsulin aspart
Interchangeable 1
Kirstyinsulin aspart-xjhz
Biosimilars 1
Meriloginsulin aspart-szjj
Source: FDA Purple Book (purplebooksearch.fda.gov), matched on the reference product’s active ingredient.
Where does this data come from?
Patents and exclusivity from the FDA Purple Book (biologics), refreshed from public FDA data. Biosimilar launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerNovo Nordisk Pharmaceutical Industries, LP
FDA applicationBLA021172 (BLA)
Labeler code00169
First marketedNov 2001
Product typeHuman Prescription Drug
Portfolio39 products on file

More NDCs from Novo Nordisk Pharmaceutical Industries, LP labeler code 00169

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
📄 FDA label
📄 FDA label 19 words ▾

No FDA label is on file for this product yet. Labels load from openFDA / DailyMed and refresh weekly.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
1.1K
Units reimbursed last 4 qtrs
26.8K
Gross reimbursed last 4 qtrs
$193.5K
Avg / prescription
$171.20
Avg / unit
$7.2113
Latest quarter Q1 2026
308Rx
Medicaid pays / mL
$7.2113
gross reimbursed
vs
NADAC / mL
$6.9287
acquisition cost
=
Spread
+$0.2826
+4% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
60% FFS 40% MCO
Fee-for-service · 678 Rx Managed care · 452 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 330 units · 5.6 per 100k residents WI Michigan: no data reported MI New York: 4,980 units · 25.4 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: no data reported PA New Jersey: no data reported NJ Massachusetts: no data reported MA California: 6,290 units · 16.1 per 100k residents CA Utah: no data reported UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 600 units · 9.7 per 100k residents MO Kentucky: 1,065 units · 23.5 per 100k residents KY West Virginia: 330 units · 18.6 per 100k residents WV Virginia: 680 units · 7.8 per 100k residents VA Maryland: 530 units · 8.6 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: 430 units · 14.0 per 100k residents AR Tennessee: no data reported TN North Carolina: 670 units · 6.2 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 410 units · 8.0 per 100k residents AL Georgia: 2,360 units · 21.4 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 5,540 units · 18.2 per 100k residents TX Florida: 2,611 units · 11.5 per 100k residents FL
Units reimbursed · per 100k residents
5.625.4
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 New York 25.4 /100k
2 Kentucky 23.5 /100k
3 Georgia 21.4 /100k
4 West Virginia 18.6 /100k
5 Texas 18.2 /100k
6 California 16.1 /100k
7 Arkansas 14.0 /100k
8 Florida 11.5 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Novolog Mix 70-30 — the program that covers self-administered drugs. 2 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Novolog Mix 70-30. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.94M
Claims incl. refills
8.3K
Beneficiaries
5.2K
Spend / beneficiary
$370.52
Spend / claim
$234.22
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.
← 00169-3303-12 · Novo 00169-3687-12 · Novo →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.